# K222820: BRM TOOL Screws, BIOPLAN Subtalar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Brm Extremities
- Decided: Dec 16, 2022 after 88 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962616 (1996). 224 ancestors in all.
No later device cites it as a predicate yet.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203773: BRM TOOL Screws, Brm Extremities Srl (2022) Summary page 5.
- K170688: PIT’Stop® implant, In2bones Sas (2017) Summary page 5.

## Indications for use
The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion, and bone fragment fixation appropriate with the size of the screw. The BIOPLAN Implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. • Flat foot treatment in children and adolescents • Congenital flat foot • Non successful long term orthopaedic treatment (shoes, insoles ...) • Tarsal coalitions • Painfully flat foot • Supple deformity in posterior tibial tendon dysfunction • Paralytic flat foot • Subtalar instability

Source page: https://510kreport.com/device/K222820
Methodology: https://510kreport.com/methodology